Justice Watch: The Alliance for Justice Blog

February 2010

Last week, the FDA announced that it lacks critical powers of oversight over medical devices submitted using the “510(k)” or “Pre-Market Notification” (PMN) process, and that it may go to Congress to request additional regulatory authority.

For the last 35 years, the FDA has annually approved approximately 3,500 devices using a 35-year-old law from Section 510(k) of the Food, Drug and Cosmetic Act. 510(k) allows the FDA to determine whether a new medical device is substantially equivalent to a device previously approved, in which case it will be quickly cleared for release onto the market. The program is popular among medical device manufacturers because it is expedient: only 50 or so devices are approved annually under the more rigorous FDA approval system. According to the Government Accountability Office, 20 high risk devices later discovered to be dangerous to consumers were mistakenly passed through the FDA under the 510(k) system last year.

In related news, last week the FDA lifted restrictions on Medtronic external defibrillators, saying that the company had met quality control requirements and could again begin unrestricted shipment worldwide. Medtronic then announced a fourth quarter dividend of $0.205 per share. Medtronic shareholders are on pace to receive over $900 million in dividends this year, while the victims of its faulty devices find their legal claims against the company preempted by FDA approval, and have no legal recourse to recover damages for medicals bills, lost wages, or pain and suffering.

Consumers have faced multiple surgeries due to faulty orthopedic implants, or found themselves shocked by faulty defibrillator leads. However, upon bringing suit, consumers have then found their legal rights nullified by the device’s prior approval by an agency that concedes it lacks the authority necessary to ensure public safety. Circumstances demand speedy legislative action to correct these injustices: passage of the Medical Device Safety Act (MDSA). MDSA would protect consumers’ right to sue when they are harmed by certain defective medical products. As Dr. Larry Kessler, a 13-year veteran of the FDA device center, points out, “The device world codified by the Medical Device Amendments of 1976 is dramatically different than where we are today 35 years later. The pace of innovation has really ramped up and the 510(k) process has been used, and in some cases people would say misused, to clear very advanced technology.”

In anticipation of the Senate Judiciary Committee’s hearing on the Office of Professional Responsibility’s (OPR) investigation into the “torture memos,” Alliance for Justice hosted a panel of experts who could speak about the findings of the OPR report.

During her introduction, moderator Nan Aron, president of Alliance for Justice stated, “regardless of OPR’s conclusion about the lawyers’ ethical conduct, the report adds to the mounting evidence that warrants a full-scale investigation of those who ordered, designed, and justified torture. The new findings must be independently investigated, and I am delighted that tomorrow the Senate Judiciary Committee will be taking the next step toward uncovering the truth.”

Panelists David Cole, Professor of Law, Georgetown University Law Center, Michael Frisch, Ethics Counsel & Adjunct Professor of Law, Georgetown University Law Center, Scott Horton, Adjunct Faculty, Columbia Law School and Contributing Editor, Harper’s Magazine, and William Yeomans Fellow in Law and Government, American University Washington College of Law discussed the findings of the OPR report, and what next steps are possible.

Bill Yeomans pointed out a gaping hole in OPR’s investigation, “we know that there was extensive contact between John Yoo and the White House, including the Office of the Vice President, but we don’t yet know what was said. This gap screams out for further investigation to determine whether DOJ’s legal views on torture were shaped by pressure from the Bush White House.”

Michael Frisch, spoke about the failure of the OPR report to consider whether the authors of the torture memos had knowingly counseled their client to engage in, or assisted in, criminal conduct. “This clear standard of ethical behavior was largely ignored in the DOJ process. Notwithstanding the conclusion that the matter not be referred to bar disciplinary authorities, those authorities remain obligated to investigate these serious allegations of professional misconduct.

David Cole, author of The Torture Memos, was disturbed by the evidence of “two tracks of law in this country, one for public consumption and one secret. At every step of the way the secret law was used to subvert the public law.”

Finally, Scott Horton, was adamant that OPR did not ask the right question.

“The question is not only whether an ethical violation occurred but whether a crime occurred. The OPR report does not address whether there was a conspiracy to torture under Rule 2340A.”

In classic DC fashion, the report on the authors of the “torture memos” was released Friday night, buried under headlines about Tiger Woods. While the Department of Justice sent the Office of Professional Responsibility (OPR) report to Congress, it was the House Judiciary Committee Chair John Conyers (D-MI) who publicly released not only the final OPR report, but also the first and second drafts of the report and the responses from Yoo and Bybee.

In contrast to most peoples’ perception of Washington, Congress can move quickly when it wants to: by 6pm, less than an hour after the report’s release, Senate Judiciary Committee Chairman Patrick Leahy (D-Vt.) announced that his panel will hold a hearing on the report next Friday morning. Leahy also called for Judge Bybee’s resignation.

“I have said before that if the Judiciary Committee, and the Senate, knew ofJudge Bybee’s role in creating these policies, he would have never beenconfirmed to a lifetime appointment to the federal bench. The right thing to dowould be for him to resign from this lifetime appointment.”

The long-awaited report is the product of a five-year investigation by OPR, and the materials released by Conyers number more than 500 pages. We will be reading and analyzing the different drafts of the report and providing more in-depth analysis as we know more.

Alliance for Justice is proud to have recently partnered with Jon and Matt to produce two short documentaries explaining why people harmed by prescription drugs or defective medical devices need to access justice through our courts. The films Hit and Run and Access Denied: the Fight for Corporate Accountability tell the story of Americans who trusted pharmaceutical and medical device manufacturers to sell safe products, were harmed as a result, and now have no ability to seek recourse for their damages. The films explain why Congress must pass the Medical Device Safety Act, which is desperately needed to end corporate immunity for manufacturers of faulty medical devices.

We hope people will take action and join with the AARP, The New England Journal of Medicine, Public Citizen, Easter Seals, the National Conference for State Legislatures, and a number of other medical and consumer advocacy groups to pass the Medical Device Safety Act in 2010.

Thanks to Jon and Matt for helping Alliance for Justice bring attention to FDA preemption and the Medical Device Safety Act, and best of luck to you at this year’s Oscars!